BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23157942 · Received September 26, 2025

    Report

    Report Number
    3019004087-2025-03643
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    PMA / PMN Number
    K231485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE ILET EVALUATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED THAT A BETA BIONICS ILET USER EXPERIENCED AN ONGOING ISSUE WITH THE DEVICE SLEEP/WAKE BUTTON NOT CONSISTENTLY RESPONDING. A DEVICE REPLACEMENT WAS ARRANGED. THERE WAS NO REPORT OF END-USER HARM OR ADVERSE EVENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244906 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown